Purisys is a trusted CDMO partner for custom pharmaceutical API and other chemical synthesis projects with capabilities unique in the industry.

Built over a 40-year history, our expertise allows us to support a diverse range of custom API development projects from proof of concept, bench chemistry to full-scale product commercialization – with particular strengths in full-service clinical Phase I/II and small volume, orphan drug commercial API GMP synthesis. Our broad ranging, and often specialized, chemistry capabilities make us the partner of choice for technically intensive and complex projects. Purisys also has an industry-leading track record in compliance with US FDA cGMPs and other global regulatory bodies. For more information on the company please visit https://purisys.com

GENERAL PURPOSE OF JOB

The Manufacturing Operator carries out tasks associated with chemical manufacturing utilizing batch logs, standard operating procedures, and work instructions under cGMP guidelines. The Manufacturing Operator adheres to all safety, quality, and compliance regulations, procedures, and guidelines, with special care given to protect the environment in which we operate.

Under direct supervision, trains to perform duties related to the preparation, manufacture, storage, shipping and handling of active pharmaceutical ingredients and intermediates/starting materials as well as routine analytical testing. All duties will be performed in compliance with standard operating procedures and as regulated by quality, environmental, and safety agencies (FDA, EPA, OSHA, DEA, etc.).

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Under supervision, operates chemical production processes by following detailed instructions. Sets up, operates and cleans production equipment used to produce intermediate or finished products for Active Pharmaceutical Ingredients, intermediate products, or raw material components. Completes all associated support activities in the production of these products.
• Possess a basic understanding of a limited number of chemical production processes within area of assignment and a working knowledge of manufacturing equipment and chemical processing principles.
• Follows and accurately completes batch records/logs, SAP transactions and other documentation associated with all production processes to ensure efficient operations and compliance with cGMP and standard operating procedures.
• Samples, labels, and properly stores raw materials when received in the warehouse.
• Performs all duties in compliance with applicable safety, health, environmental, and regulatory (cGMP, DEA, FDA, OSHA) guidelines. Complies with all company and site policies and procedures.
• Proper operation of process controls, BPCS systems, pneumatic, hydraulic and electrical equipment as detailed in procedures to product materials in a safe and cGMP environment.
• Recognizes and documents “abnormal” operating conditions with proper response including immediate notification of supervision.
• Oversees manufacturing process composed of steps such as set-up, loading, unloading, processing, drying, documentation, and follow-up.
• Must be available for overtime work on a scheduled or emergency basis.
• Must be able to work on a rotating shift basis as necessary.

ADDITIONAL POSITION REQUIREMENTS

• Performs all duties with attention to quality, safety and environmental matters. Items include: wearing appropriate personal protective equipment, recognizing, reporting, and appropriately responding to hazards in the work area (spills/accidents/near misses), maintaining proper housekeeping at all times, and properly labeling and storing chemicals.
• Complete RCRA training within first six months of employment and annually thereafter.
• Complete all regulatory training as assigned (cGPM, ISO14001, OSHA, DEA, etc.).
• Complete Operator Training Program and/or Laboratory Analyst Training Program according to established guidelines.
• Successfully completes any additional job training requirements.
• Continuously looks for ways to simplify or improve products, services, systems, and processes to achieve business goals, e.g., improve yield, cycle time, quality, and productivity.
• Makes a positive contribution through demonstration of ability to seek out assistance from co-workers as needed; to suggest ways to improve upon current operations practices and systems; and to learn new skills, procedures and processes.
• Interfaces with operations and technical personnel.

SUPERVISORY RESPONSIBILITIES

None.

QUALIFICATIONS

EDUCATION and/or EXPERIENCE

• High school diploma or general education degree (GED).
• Two to four years related experience and/or training or equivalent combination of education and experience.
• Work experience in chemical, pharmaceutical, or industry that complies with cGMP is preferred.

LANGUAGE SKILLS

• Read and interpret documents such as safety rules, operating and maintenance instructions, government regulations and procedure manuals.
• Reads, analyzes, and interprets complex documents.
• Responds effectively to inquiries or complaints.
• Write routine reports, operating procedures, and correspondence with supervisory assistance if required.

MATHEMATICAL SKILLS

• Add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals.
• Compute rate, ratio, and percent and draw and interpret bar graphs.
• Calculate figures and amounts such as proportions, percentages, area, and volume.
• Perform conversions from metric units to English units and vice versa.

REASONING ABILITY

• Follow and interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
• Solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
• Applies principles of logical or scientific thinking to a wide range of intellectual and practical problems.
• Deals with nonverbal symbolism (formulas, scientific equations, graphs, etc,).

OTHER SKILLS ABILITIES OR QUALIFICATIONS

• Operating skills of manufacturing equipment, tools, and hand/fork trucks.
• Basic PC navigation such as the ability to enter data into programs/software applications as instructed and uses software applications for mail, word processing, spreadsheets and other job specific needs.
• Perform a variety of tasks, changing tasks frequently, staying focused, maintaining attention to detail, with a focus on Safe and Right First Time production.
• Work well with others in a team environment, influencing people in opinions and attitudes.
• Possesses a sense of duty; is willing to go the extra mile to get the job done.
• Takes initiative as problems and/or opportunities arise; is action oriented; does all that should be done, not only as directed.
• Must be able to work in situations where speed and sustained attention are essential, performing a variety of tasks without loss of production.

PHYSICAL DEMANDS

• While performing the duties of this job, the employee is regularly required to stand; walk; use hands to finger, handle, or feel; climb, bend and stoop; and reach with hands and arms.
• The employee is frequently required to talk or hear and taste or smell.
• Must have the ability to work from ladders or platforms up to 30 feet in the air and the ability to lift, push or pull up to 50 pounds.
• Specific vision abilities required by this job include close vision, distance vision, color vision, depth perception, and ability to adjust focus.
• Must be able to qualify for respiratory protective equipment use.

Qualified applicants will be considered without regard to race, color, religion, creed, sex, sexual orientation, gender identity, marital status, national origin, age, veteran status, disability or any other protected class.

Job Type: Full-time

Pay: From $22.00 per hour

Benefits:

• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Compensation package:

• Bonus opportunities

Schedule:

• Day shift

Application Question(s):

• Are you willing to undergo a background check, in accordance with local law/regulations?

Education:

• High school or equivalent (Preferred)

Experience:

• chemical, pharmaceutical or industry that complies with cGMP: 1 year (Preferred)

Work Location: In person